China · National Medical Products Administration · New drugs
Review target
30 working days
official guidance
Legal time limit
-
Not published
Steps
5
5 requirements
Application fee
-
Since September 2025, qualifying clinical trial applications for category 1 innovative drugs can be reviewed within 30 working days of acceptance, instead of the general 60 day implied approval. Applicants must prepare the lead trial site and ethics review in parallel and start the trial within 12 weeks of approval. Category 1 innovative traditional Chinese, chemical or biological drugs that are national priority products, qualifying pediatric, rare disease or traditional Chinese medicine innovations, or global simultaneous development products.
The official review target is 30 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Site and ethics preparation; 2. Clinical trial application marked 30 day channel; 3. Acceptance (5 days); 4. Review and approval (30 days); 5. Trial start (84 days).
Outcome: Clinical trial approval within the shorter limit.
Legal basis: NMPA Announcement 2025 No. 86; Opinions of the General Office of the State Council (2024 No. 53)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 119 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. These are official maximum working-day limits in the rules, not actual review times. | 30 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in China: Marketing authorization for an innovative drug, Improved new drug (known active substance), Generic chemical drug, Nonprescription (OTC) drug application, Vaccine registration, Breakthrough therapy procedure, Conditional approval, Priority review and approval, Special approval for public health emergencies, Urgent import in the Hainan Boao Lecheng pilot zone, Hong Kong and Macao drugs and devices in the Greater Bay Area, Small-quantity urgent import by hospitals, Expanded access at clinical trial sites. See all routes on the China page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.